Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT03263403
Eligibility Criteria:
Inclusion Criteria:
1. Apparently healthy adult of 18 to 45 years of age.
2. Sex: Male, Female and Transgender
3. Apparently healthy based on a medical history taken prior to vaccination. Any underlying chronic illness must be documented to be in stable condition.
4. Women with child bearing potential must be non pregnant which will be confirmed by negative urine pregnancy test during screening and prior to vaccination on day 0 as well. Moreover, medical history will be taken thoroughly by study physician from the woman of childbearing age to completely exclude the probability of pregnancy.Women who are married and living with a partner must agree to use a reliable contraceptive method to prevent pregnancy until final follow-up following vaccination. However abstinence is also acceptable.
Exclusion Criteria:
1. Prior history of Meningitis infection or vaccination with any Meningococcal vaccine.
2. Prior history of taking any other polysaccharide vaccine (Pneumococcal Vaccine, Typhoid Vaccine) in last 6 months.
3. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
4. Recent febrile illness (within last two weeks).
5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician.
6. Known or suspected hypersensitivity to any component of Meningococcal ACWY polysaccharide vaccine.
7. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g, systemic corticosteroids). Does not include topical and inhaled steroids.
8. Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
9. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03263403
Study Brief:
Protocol Section:
NCT03263403